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These measures may be appropriate for evaluating the efficacy of anti-pruritic treatment in patients with chronic kidney disease-associated pruritus (CKD-aP). This study evaluated the psychometric validity and meaningful within-patient change (MWPC) thresholds of these two measures in patients with moderate-to-severe CKD-aP undergoing hemodialysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methodology<\/jats:title>\n                    <jats:p>\n                      Content validity interviews for the Skindex-10 were conducted in 23 patients. Psychometric properties of the Skindex-10 questionnaire and 5-D Itch scale were assessed using data collected from a phase 2 randomized controlled trial of an anti-pruritic treatment in patients with moderate-to-severe CKD-aP. As part of the trial, the patients (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009174) had completed the Skindex-10 and 5-D Itch measures at baseline (Day 1, pre-treatment); Weeks 2, 4, 6; and end of treatment (Week 8). Anchor-based methods were used to determine MWPC score thresholds, which were verified in two very similar, larger phase 3 cohorts (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009378 and\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009471).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Content validity interview participants considered the Skindex-10 questionnaire to be straightforward, relevant, and comprehensive. Scores from both measures showed moderate-to-strong internal consistency (Cronbach\u2019s \u03b1\u2009\u2265\u20090.74), and moderate test-retest reliability (intraclass correlation coefficients\u2009\u2265\u20090.67, Week 2 vs. Week 4) for patients stable on the similar Patient Global Impression of Worst Itch Severity measure. Construct validity analyses indicated that total scores and most domains of the Skindex-10 and 5-D Itch significantly correlated with other measures of itch. Skindex-10 and 5-D Itch total scores were also significantly different (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009\u2264\u20090.0015) between distinct groups created based on conceptually related pruritus measures (known-groups validity). Anchor-based analyses indicated that a reduction from baseline of \u2265\u200915 points on the 0\u201360 scale for Skindex-10 total score, and of \u2265\u20095 points on the 5\u201325 scale for 5-D Itch total score, represented appropriate clinically meaningful within-patient changes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Skindex-10 and 5-D Itch showed good psychometric properties for measuring itch intensity and health-related quality of life in patients with moderate-to-severe CKD-aP. These results support their use in evaluating treatment efficacy in this patient population.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s41687-025-00973-3","type":"journal-article","created":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T15:55:42Z","timestamp":1764258942000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Psychometric validation and meaningful change thresholds of the Skindex-10 questionnaire and 5-D Itch scale for assessing itch in patients with chronic kidney disease-associated pruritus"],"prefix":"10.1186","volume":"10","author":[{"given":"Margaret K.","family":"Vernon","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Munera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert H.","family":"Spencer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Warren","family":"Wen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3584-1665","authenticated-orcid":false,"given":"Fr\u00e9d\u00e9rique","family":"Menzaghi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,27]]},"reference":[{"issue":"9","key":"973_CR1","doi-asserted-by":"publisher","first-page":"1626","DOI":"10.1038\/sj.ki.5000251","volume":"69","author":"I Narita","year":"2006","unstructured":"Narita I, Alchi B, Omori K et al (2006) Etiology and prognostic significance of severe uremic pruritus in chronic Hemodialysis patients. 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The original trials were conducted in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonisation guidelines for Good Clinical Practice, and applicable regulatory requirements. The trial protocols were approved by the institutional review board at each participating institution. All participants provided their written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MKV was employed by Evidera when the study was conducted. FM, CM, WW, and RHS were employed by Cara Therapeutics, Inc. when the study was conducted.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"2"}}